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Stem Cells in the News – Can They Repair That Much?

Last week, we posted some advances in stem cells research that could in the future target and treat certain conditions in the brain where there is a diminishing function of critical neurons. These stem cells have the potential to function as neurons and restore function if appropriately directed. An area of promise relates to the treatment of strokes. Strokes occur when blood flow to the brain is interrupted and a portion of the brain dies. As a consequence, there is a loss of function. Researchers have explored the feasibility of using stem cells to restore function following strokes.

As an example, an article in the Smithsonian magazine catalogues translation of stem cell therapy in a patient who had suffered a stroke: “A Neurosurgeon’s Remarkable Plan to Treat Stroke Victims with Stem Cells.” The neurosurgeon was able to deliver stem cells to the region of the brain that had been damaged by the stroke. This particular treatment was done as part of an FDA protocol.

As we reported further research is needed in order to advance stem cell therapy for a wide range of illnesses. Hence most of the current data on stem cells is experimental. A caveat to our readers, therefore, is that many of the claims to “cure” brain diseases such as Alzheimer’s disease and others using stem cells and supplement do not represent clinical level evidence and therefore misleading. This is universally true if the therapy or supplement in questions has not been evaluated via an FDA protocol.

“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s. Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries. Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care – and we will continue to take action to protect patients and caregivers from misleading, unproven products. Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago. That law sought to achieve the right balance between preserving consumers’ access to lawful supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”

From FDA Commissioner Scott Gottlieb, M.D.

From the FDA

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